System for meniscal repair using suture implant cinch construct

ABSTRACT

A system for repairing tears in soft tissue, e.g., meniscal tissue, by employing cinch stitching. More specifically, the present invention provides an apparatus for meniscal repair using a suture implant construct. The suture implant construct includes a first and second implant which are connected to each other via a length of suture. The implants are designed to be loaded on external surfaces of the first and second trocars.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation of U.S. patent application Ser. No. 14/608,623,filed Jan. 29, 2015, now U.S. Pat. No. 10,363,024, which is divisionalof U.S. patent application Ser. No. 12/397,272, filed Mar. 3, 2009, nowU.S. Pat. No. 8,961,538, which claims the benefit of U.S. ProvisionalApplication No. 61/033,644, filed Mar. 4, 2008, the entire disclosuresof which are incorporated by reference herein.

FIELD OF THE INVENTION

The present invention relates to methods of arthroscopic surgery and,more specifically, to an improved method of repairing tears in tissue,such as meniscal tissue.

BACKGROUND OF THE INVENTION

Tissue repair requires the surgeon to pass suture material throughselected tissue, form a plurality of surgical knots extracorporeally andthen move the knots into position adjacent the desired tissue to besutured. In such procedures, the surgeon must manually tie the knots onthe suture strands after the suture is threaded through the selectedtissues to be sutured. Knot tying during surgery, particularlyarthroscopic surgery, is tedious and time-consuming. There is also atendency for the knots to deform or collapse as the surgeon manuallyforces the knots down into the proper position.

Accordingly, a need exists for an improved method of repairing tears insoft tissue (such as the meniscus) which does not require multiplesuture knots.

SUMMARY OF THE INVENTION

The present invention provides a system and method for repairing tearsin soft tissue, e.g., meniscal tissue, by employing cinch stitching.More specifically, the present invention provides apparatus and methodsfor meniscal repair using a suture implant construct. The suture implantconstruct comprises a first and second implant which are connected toeach other via a length of suture. The implants are designed to beloaded on external surfaces of the first and second trocars.

Other features and advantages of the present invention will becomeapparent from the following description of the invention, which refersto the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a side view of a first and second trocars of ameniscal cinch assembly according to an embodiment of the presentinvention;

FIG. 2 is a side view of the depth stop to be assembled to the first andsecond trocars of FIG. 1 ;

FIG. 3 illustrates a side view of first and second trocars of FIG. 1(with a depth stop attached);

FIG. 4 illustrates an enlarged view of the detail A of FIG. 3 ;

FIG. 5 illustrates a perspective view of the meniscal cinch assembly ofthe present invention;

FIG. 6 illustrates a top view of the meniscal cinch assembly of thepresent invention with a first and second implant seated;

FIG. 7 illustrates a side view of the first implant of the meniscalcinch assembly of FIG. 6 ;

FIG. 8 illustrates a side view of the second implant of the meniscalcinch assembly of FIG. 6 ;

FIG. 9 illustrates a side view of the first and second implants of themeniscal cinch assembly of FIG. 6 , connected by a flexible strand;

FIG. 10 illustrates a side view of the meniscal cinch assembly of thepresent invention with a first and second implant seated;

FIG. 11 illustrates a perspective view of the first and second trocarsof the meniscal cinch assembly of the present invention, prior tosliding the trocar/suture assembly within the delivery hand piece;

FIG. 12 illustrates another perspective view of the meniscal cinchassembly of the present invention;

FIG. 13 illustrates another perspective view of the meniscal cinchassembly of the present invention;

FIG. 14 illustrates a perspective view of an implant used with themeniscal cinch assembly of the present invention;

FIG. 15 illustrates a side view of the implant of FIG. 14 ;

FIG. 16 illustrates a lateral view of the implant of FIG. 14 ;

FIG. 17 illustrates a bottom view of the implant of FIG. 14 ;

FIGS. 18-24 illustrates various steps in the formation of a knotassembly suture construct used with the meniscal cinch assembly of thepresent invention; and

FIGS. 25-35 illustrate various steps of a method of arthroscopic repairusing the meniscal cinch assembly of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

In the following detailed description, reference is made to variousspecific embodiments in which the invention may be practiced. Theseembodiments are described with sufficient detail to enable those skilledin the art to practice the invention, and it is to be understood thatother embodiments may be employed, and that structural and logicalchanges may be made without departing from the spirit or scope of thepresent invention.

The present invention provides methods and systems for repairing tearsin soft tissue (such as the meniscus) employing cinch stitching. Inparticular embodiments, the present invention provides a meniscal cinchassembly comprising first and second trocars, a depth stop adapted tosecurely engage one of the trocars, and a suture implant constructconfigured to be loaded onto external surfaces of the first and secondtrocars of the meniscal cinch assembly.

The suture implant construct of the present invention comprises a firstand second implant which are connected to each other via a length ofsuture. The implants are designed to be loaded on external surfaces ofthe first and second trocars. Each implant has a through-hole running ina direction parallel to the longitudinal axis of the implant and throughwhich suture is inserted. As detailed below, the implants are configuredwith opposing planar end faces that are perpendicular to thelongitudinal axis of the implant.

The present invention also provides methods for soft tissue fixation(such as meniscal repair, for example) by cinch stitching. According toan exemplary embodiment, the method comprises the steps of: (i)providing a meniscal cinch assembly comprising first and second trocars,a depth stop adapted to securely engage one of the trocars, and a sutureimplant construct having first and second implants loaded on theexternal surface of the first and second trocars; and (ii) passing atleast one of the first and second implants through tissue to be repaired(for example, labral tissue of the glenoid or meniscal knee tissue).

Referring now to the drawings, where like elements are designated bylike reference numerals, FIGS. 1-13 illustrate a meniscal cinch assembly100 of the present invention (comprising first and second trocars 10,20; depth stop 30; and first and second implants 40, 50). FIGS. 14-17illustrate implant 40 used with the meniscal cinch assembly 100 of thepresent invention. FIGS. 18-23 illustrate various steps in the formationof a knot assembly suture construct 60 (comprising first and secondimplants 40, 50 attached by a flexible strand 45) used with the meniscalcinch assembly 100 of the present invention. FIG. 24 illustrates thefinal knot assembly suture construct 60 of FIG. 23 . FIGS. 25-35illustrate various steps of a method of arthroscopic repair using themeniscal cinch assembly 100 of the present invention.

Reference is now made to FIGS. 1-13 which illustrate meniscal cinchassembly 100 of the present invention including an actuating mechanismconfigured to operate a suture implant construct. As shown in thedrawings, meniscal cinch assembly 100 (FIGS. 5, 12 and 13 ) comprises apush rod assembly 110 (a trocar assembly 110) (FIGS. 1-4 ), a sutureimplant construct 60 (FIG. 9 ) fully seated onto the trocar assembly110, and a delivery system 120 (FIG. 11 ) for releasing and advancingimplants of the suture implant construct 60 onto the exterior surface ofa meniscus.

As shown in FIGS. 1-4 , trocar assembly 110 of the meniscal cinchassembly 100 comprises a first trocar 10 in communication with a secondtrocar 20, the first and second trocars being designed to carry ontotheir external surfaces a first implant 40 (on the first trocar 10) anda second implant 50 (on the second trocar 20).

FIG. 2 illustrates depth stop 30 of the meniscal cinch assembly 100comprising an upper slot 31, a lower slot 33, and a depth slot 35. Depthstop 30 is designed to ensure appropriate release of the first andsecond implants 40, 50 into the meniscal tissue to be repaired (i.e., itlimits the protrusion distance of the implant loaded trocar beyond thetip of the meniscal cinch cannula 100). Uncontrolled advancement of theimplants into the damaged meniscal tissue may have unwanted consequencesand may require additional repair steps.

In use, the second trocar 20 is slid into the bottom hole of the depthstop 30 to machined groove 37 (FIGS. 1 and 3 ) and snapped upward intothe upper slot 31 of depth stop 30 to secure (see detail A of FIG. 4 ).The first trocar 10 is slid into the bottom hole of the depth stop 30until the handle mates with depth stop 30, as shown in FIG. 3 .

FIGS. 6-10 illustrate the suture construct 60 with connected first andsecond implants 40, 50 mounted on the first and second trocars 10, 20.The suture construct is assembled to the first and second trocars 10, 20by sliding the long lead first implant 40 onto the first trocar 10,oriented and fully seated as shown in FIG. 7 (detail B). Withouttwisting the suture leads, short lead second implant 50 is slid onto thesecond trocar 20, oriented and fully seated as shown in FIG. 8 (detailC). With implants 40, 50 fully seated, ensure that slight suture slackbetween implants is acceptable, and also that the suture is layingagainst the trocars 10, 20 and the free end is not twisted around thesuture construct, trocars or depth stop. The sliding knot must not betensioned tight and located beyond the second implant. Preferably, theconstruct 60 is loose and tangle free before insertion.

The implants 40, 50 may be formed of PEEK or similar material andflexible strand 45 may be a suture and/or may comprise a bioabsorbablematerial, such as PLLA or one of the other polylactides, for example,and/or may be formed of twisted fibers having strands of a contrastingcolor added to the braided threads, to make the suture more visibleduring surgical procedures. In exemplary embodiments, strand 45 maycontain strands of a high strength suture material, such as ArthrexFiberWire® suture disclosed in U.S. Pat. No. 6,716,234, incorporatedherein by reference.

Reference is made to FIGS. 11-13 . The subassembly 110 of FIG. 10 isslid into appropriate holes 122 and ratchet grooves 124 of deliverydevice 120 (FIG. 11 ) to obtain the meniscal cinch assembly 100 shown inFIGS. 12 and 13 . The subassembly 110 is slid in until reaching depthstop 30. The tabs 38 of depth stop 30 are squeezed together to advancethe subassembly 110 to first ratchet tooth 128 (FIG. 12 ). The tabs 38of the stop depth 20 are then released to secure the subassembly in thedocked position.

As detailed below, when the first trocar is pulled from the meniscus,the first implant 40 makes contact with the meniscal tissue and, as aresult, is released from the exterior surface of the first trocar 10. Asthe first implant 40 is released from the exterior surface of the firsttrocar 10, it flips about 90-degrees and becomes secured on the exteriorsurface of the meniscus. The first trocar 10 is then fully removed fromthe cannula. The operation is repeated with the second trocar 20 loadedwith the second implant 50. Once the second implant 50 is released, theimplant flips about 90-degrees and becomes secured on the exteriorsurface of the meniscus adjacent to the first implant 40. The meniscalcinch assembly is then removed from the knee.

FIGS. 14-17 illustrates various views of implant 40 used with themeniscal cinch assembly 100 of the present invention. As shown in FIG.14 , for example, the implant has a cannulation 42 in a direction aboutparallel to the longitudinal axis 43 of the implant and through whichsuture is inserted. The implant also has opposing end faces 46, 48 (FIG.14 ) that are about perpendicular to the longitudinal axis of theimplant.

FIGS. 18-24 illustrate various steps in the formation of a knot assemblysuture construct 60 (comprising first and second implants 40, 50attached by a strand 45) used with the meniscal cinch assembly 100 ofthe present invention. FIG. 24 illustrates the final knot assemblysuture construct 60 of FIG. 23 . Knot assembly suture construct 60withstands about 45N tensile pull test.

In use, a single braided implant construct is threaded onto prebraidedlong suture 45 (for example, an 18 inch suture) oriented as shown inFIG. 18 . The right tail lead is wrapped under the post, as shown inFIG. 19 . The tail lead is wrapped over the post and passed throughopening exiting out under the right lead, as shown in FIG. 20 . The tailis wrapped around the right lead and post, as shown in FIG. 21 . Thetail is wrapped around the post back toward opening and over cross lead,as illustrated in FIG. 22 . The tail is tucked in the second opening,exiting out under the right lead (FIG. 23 ). The sliding knot istensioned down to the desired dimension (FIG. 24 ) to obtain the finalconstruct 60.

Reference is now made to FIGS. 25-35 which illustrate various steps of amethod of arthroscopic repair using the meniscal cinch assembly 100 ofthe present invention. The methods of the present invention distributesuture pressure to tissue, reduce tissue cut, and allow for acceleratedtissue healing that is achieved with minimal knot tying.

For exemplary purposes only, the invention will be described below withreference to an arthroscopic meniscal knee joint repair. However, theinvention is not limited to this exemplary embodiment and hasapplicability to any reattachment of tissue to tissue (for example,reattachment of labral tissue (cartilage) to the glenoid).

FIGS. 25-35

The repair 200 (FIG. 35 ) according to an exemplary cinch stitchingtechnique of the present invention includes the following steps:

FIG. 25 : The meniscal cinch is designed to be used through a lowarthroscopic portal, near the surface of the tibia 210. A measurement istaken to approximate the distance between the entry point of the implant40, 50 to the knee capsule. The measurement can be taken with either ameasurement probe or the graduated tip of the meniscal cinch cannula(where each line represents about 2 mm).

FIG. 26 : The depth stop 30 on the meniscal cinch handle is set to thedistance measured above, by squeezing the tips together and sliding thedepth stop 30 forward. The depth stop 30 is set to a distance aboutequal to the measurement in the step of FIG. 25 . Each line on thehandle represents about 2 mm.

FIG. 27 : A cannula (for example, a shoehorn cannula) may be placed intothe working portal before inserting the meniscal cinch device 100. Placethe tip of the meniscal cinch cannula near the tear. The tip of thecannula may be used to reduce the tear prior to deployment of the firsttrocar 10. Alternatively, the tip of the first trocar may be advancedpast the tip of the cannula to be used to reduce the tear. The trocarshould not be pulled back into the cannula after it has been advanced asit could prematurely deploy the implant.

FIG. 28 : The tip of the meniscal cinch cannula is placed in contactwith, but does not pierce, the meniscus near the meniscal tear. Thefirst implant 40 is advanced through the meniscus by pushing the firsttrocar 10 forward until the trocar handle makes contact with the depthstop 30 and the cannula rests on the surface of the meniscus. As thefirst trocar 10 is pulled from the meniscus, the first implant 40 makescontact with the meniscal tissue and as a result is released from theexterior surface of the first trocar 10. As the first implant 40 isreleased from the exterior surface of the first trocar 10, it flipsabout 90-degrees and becomes secured on the exterior surface of themeniscus.

FIG. 29 : The first trocar 10 is then removed from the cannulacompletely. A slight downward force on the first trocar 10 duringremoval ensures that it does not interfere with the second trocar 20.

FIG. 30 : Push down on the second trocar 20, to release it from theholding position. Next, the tip of the cannula is moved to the secondinsertion point so that the tip of the cannula is in contact with, butdoes not pierce, the meniscus.

FIGS. 31 and 32 : The second trocar 20 is advanced forward by pushingthe trocar handle. The second trocar 20 is advanced through the meniscusuntil the trocar handle makes contact with the depth stop 30 and thecannula rests on the surface of the meniscus. Suture slack created byadvancing the second trocar 20 may be reduced partially by gentlytensioning external suture near the handle. Stop tensioning ifresistance is felt.

FIG. 33 : The second trocar 20 is then fully removed from the cannula.While the second trocar 20 is being removed, the second implant 50 isreleased from the exterior surface of the second trocar 20. The secondimplant 50 then flips 90-degrees and becomes secured on the exteriorsurface of the meniscus adjacent to the first implant 40. The meniscalcinch assembly 100 is then removed from the joint. The external sutureis tensioned to advance the knot to the meniscus.

FIG. 34 : The external suture is threaded through the tip of a suturepassing instrument 150 such as a knot pusher-suture cutter instrument150. The knot is pushed while pulling tension on the free end of suture.The knot is advanced until it is countersunk into the meniscal tissue.

FIG. 35 : The trigger on the handle of the knot pusher-suture cutter 150is then advanced to cut the suture (the suture is pulled in line withthe cutter 150 and rotation of handle is avoided while suture is cut).The cutter is removed to obtain the final construct 200 (with theimplants in a horizontal orientation). Alternatively, the implants maybe inserted in a vertical orientation (a vertical mattress stitch).

The meniscal cinch assembly 100 of the present invention allows surgeonsto repair meniscus tears with an all-inside arthroscopic techniqueeliminating the need for accessory incisions required for traditionalinside/out techniques that often result in additional morbidity. Basedon the tear pattern and location, the meniscal cinch assembly 100 of thepresent invention gives surgeons the option of horizontal or verticalmattress repair with a flexible strand (such as a #2 FiberWire suture,for example). The present sliding knot and the FiberWire propertiescreate a secure, low profile knot that can be countersunk into themeniscus. Depending on the exact location and pattern, posterior horntears can be repaired through standard ipsilateral or contralateralarthroscopy portals. The meniscal cinch assembly 100 may be placedthrough the contralateral or accessory contralateral portal for tearsinvolving the body of the meniscus.

Although the present invention has been described in connection withpreferred embodiments, many modifications and variations will becomeapparent to those skilled in the art. While preferred embodiments of theinvention have been described and illustrated above, it should beunderstood that these are exemplary of the invention and are not to beconsidered as limiting. Accordingly, it is not intended that the presentinvention be limited to the illustrated embodiments, but only by theappended claims.

What is claimed is:
 1. A system for repairing a soft tissue, comprising:a first implant; a second implant; a flexible strand connecting thefirst implant and the second implant; a sliding knot in the flexiblestrand that is adjustable for reducing a length of the flexible strandthat is located between the first implant and the second implant; and adelivery system for implanting the first implant and the second implantinto the soft tissue, wherein the delivery system includes: a handle; anelongated shaft connected to the handle; a push rod assembly movable tocarry the first implant and the second implant through the elongatedshaft, wherein the push rod assembly includes a first push rod and asecond push rod that are both slidably received within the handle; and asingle retractable depth stop adjustable to control an insertion depthof both the first implant and the second implant, wherein theretractable depth stop is adjustable between a first position and asecond position relative to the handle and the push rod assembly,wherein the first position establishes a first insertion depth of thefirst and second implants and the second position establishes a second,different insertion depth of the first and second implants.
 2. Thesystem as recited in claim 1, wherein the first implant is carried bythe first push rod and the second implant is carried by the second pushrod.
 3. The system as recited in claim 1, wherein the first push rod isslidable within a first slot formed in the handle and the second pushrod is slidable within a second slot formed in the handle.
 4. The systemas recited in claim 1, wherein the first push rod includes a firsthandle and the second push rod includes a second handle, and the firsthandle and the second handle are separate components from both theretractable depth stop and the handle of the delivery system.
 5. Thesystem as recited in claim 1, wherein the depth stop includes a lengththat extends along a first longitudinal axis that is parallel to asecond longitudinal axis of the elongated shaft.
 6. The system asrecited in claim 1, wherein the first implant and the second implant arePEEK implants.
 7. The system as recited in claim 1, wherein the depthstop includes an extension that extends in a direction away from thehandle.
 8. The system as recited in claim 7, wherein the extensionextends along an axis that is parallel to a longitudinal axis of theelongated shaft.
 9. The system as recited in claim 7, wherein theextension extends in a direction that is transverse to a longitudinalaxis of the depth stop.
 10. The system as recited in claim 1, comprisinga plurality of depth measurement lines located on a tip of the elongatedshaft.
 11. The system as recited in claim 1, wherein the elongated shaftincludes a curved tip.
 12. A system for repairing a soft tissue,comprising: a first implant; a second implant; a flexible strandconnecting the first implant and the second implant; a sliding knot inthe flexible strand that is adjustable for reducing a length of theflexible strand that is located between the first implant and the secondimplant; and a delivery system for implanting the first implant and thesecond implant into the soft tissue, wherein the delivery systemincludes: a handle; an elongated shaft connected to the handle; a firstpush rod movable to carry the first implant through the elongated shaft;a second push rod movable to carry the second implant through theelongated shaft; and a single retractable depth stop adjustable relativeto the handle or the elongated shaft for controlling an insertion depthof both the first implant and the second implant, wherein theretractable depth stop is adjustable between a first position thatestablishes a first insertion depth of the first and second implants anda second position that establishes a second, different insertion depthof the first and second implants.